REFERENCE CODE GDHCER046 PUBLICAT ION DATE OCTOBER 2013 DIABETIC FOOT ULCERS - EPIDEMIOLOGY FORECAST TO 2022

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REFERENCE CODE GDHCER046 PUBLICAT ION DATE OCTOBER 2013 DIABETIC FOOT ULCERS -

Executive Summary Diabetic foot ulcers (DFUs) are a major complication of diabetes that occurs as a result of trauma to or extreme pressure on any part of the foot (Fard et al., 2007; Veves et al., 1992). The lifetime risk of an individual with diabetes developing a DFU is approximately 25%, according to a meta-analysis of studies conducted during 1980 2004 (Singh et al., 2005). DFUs have become an increasingly significant public health concern in both the developed and the developing world, and are a major cause of hospitalizations, as well the leading cause of lower-extremity amputations in diabetics (Jeffcoate and Harding, 2003). Globally, the morbidity associated with DFUs varies widely, with the prevalence ranging from 1.4% in the UK to approximately 12% in Algeria (Boulton, 2000; Lavery et al., 2003; Reiber, 2001). Given the increasing prevalence of diabetes, coupled with the aging population, the burden of complications related to diabetes, such as DFUs, is also likely to increase over the next 20 years (Boulton et al., 2005). As shown in the figure below, GlobalData epidemiologists forecast that the total prevalent cases of DFUs in the six major markets (6MM) (US, France, Germany, Italy, Spain, and UK) will grow from 3,811,190 cases in 2012 to 5,647,926 cases in 2022, at an Annual Growth Rate (AGR) of 4.82%. Approximately 80% of the total prevalent cases of DFUs will be in the US, with the number of cases increasing from 2,842,976 cases in 2012 to 4,328,256 cases in 2022, at an AGR of 5.22%. The increase in the number of total prevalent cases of DFUs in the 6MM is the result of changing population demographics and GlobalData s predicted increase in the diagnosed prevalent cases of diabetes in the 6MM. 6MM, Total Prevalent Cases of DFUs, Ages 20 Years, Men and Women, N, 2012 and 2022 Markets 6MM US 5EU Spain Germany France Italy UK 1,319,674 968,214 355,535 262,528 245,446 220,073 298,259 190,467 225,939 162,222 194,495 132,924 3,811,190 4,328,256 2,842,976 5,647,926 2022 2012 0 2,000,000 4,000,000 6,000,000 Total Prevalent Cases of DFUs (N) Source: GlobalData; Abbott et al., 2005; CDC, 2003 5EU = France, Germany, Italy, Spain, and UK; 6MM = US and 5EU 2

Executive Summary This report provides an overview of the risk factors, comorbidities, and the global and historical epidemiological trends for DFUs in the 6MM. In addition, the report includes a 10-year epidemiological forecast for the total prevalent cases of DFUs in the diagnosed diabetic population segmented by age (ages 20 to 85 years), sex, and the proportion of diabetic foot infections in these markets. To forecast the total prevalent cases of DFUs in the diagnosed diabetic population segmented by age and sex, and the proportion of diabetic foot infections, in the 6MM, GlobalData epidemiologists used nationally-representative studies published in peer-reviewed journals. 3

Table of Contents 1 Table of Contents 1 Table of Contents... 4 1.1 List of Tables... 6 1.2 List of Figures... 6 2 Introduction... 7 2.1 Catalyst... 7 2.2 Related Reports... 8 2.3 Upcoming Reports... 8 3 Epidemiology... 9 3.1 Disease Background... 9 3.2 Risk Factors and Comorbidities... 9 3.2.1 An Increased Duration of Diabetes Triples the Risk of Dfus... 10 3.2.2 Men Diabetics are at Higher Risk for Dfus than Women Diabetics... 11 3.3 Global Trends... 11 3.3.1 US... 12 3.3.2 5EU... 13 3.4 Forecast Methodology... 14 3.4.1 Sources Used... 15 3.4.2 Sources Not Used... 17 3.4.3 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Diabetes... 18 3.4.4 Forecast Assumptions and Methods, Diabetic Foot Ulcers... 21 3.5 Epidemiological Forecast for DFUs (2012 2022)... 24 3.5.1 Total Prevalent Cases of DFUs... 24 4

Table of Contents 3.5.2 Age-Specific Total Prevalent Cases of DFUs... 26 3.5.3 Sex-Specific Total Prevalent Cases of DFUs... 28 3.5.4 Total Prevalent Cases of Diabetic Foot Infections... 30 3.6 Discussion... 32 3.6.1 Epidemiological Forecast Insight... 32 3.6.2 Limitations of the Analysis... 32 3.6.3 Strengths of the Analysis... 33 4 Appendix... 34 4.1 Bibliography... 34 4.2 About the Authors... 38 4.2.1 Epidemiologists... 38 4.2.2 Reviewers... 38 4.2.3 Global Director of Epidemiology and Health Policy... 39 4.2.4 Global Head of Healthcare... 40 4.3 About GlobalData... 41 4.4 About EpiCast... 41 4.5 Disclaimer... 42 5

Table of Contents 1.1 List of Tables Table 1: Risk Factors for DFUs... 10 Table 2: Epidemiological Sources Used to Forecast the Total Prevalence of DFUs and Diabetic Foot Infections in the Diagnosed Diabetic Population... 15 Table 3: 6MM, Total Prevalent Cases of DFUs, Ages 20 Years, Both Sexes, N, 2012 2022... 25 Table 4: 6MM, Total Prevalent Cases of DFUs, by Age, Both Sexes, N, (Row %), 2012... 27 Table 5: 6MM, Total Prevalent Cases of DFUs, by Sex, Ages 20 years, N (Row %), 2012... 29 Table 6: 6MM, Total Prevalent Cases of Diabetic Foot Infections, Ages 20 years, Both Sexes, N, 2012 2022... 31 1.2 List of Figures Figure 1: 6MM, Total Prevalent Cases of DFUs, Ages 20 Years, Both Sexes, N, 2012 2022... 25 Figure 2: 6MM, Total Prevalent Cases of DFUs, by Age, Both Sexes, N, 2012... 28 Figure 3: 6MM, Total Prevalent Cases of DFUs, by Sex, Ages 20 Years, N, 2012... 30 Figure 4: 6MM, Total Prevalent Cases of Diabetic Foot Infections, Ages 20 Years, Both Sexes, N, 2012 2022... 31 6

Introduction 2 Introduction 2.1 Catalyst Diabetic foot ulcers (DFUs) are a major complication of diabetes and the most common foot injury in diabetics (Fard et al., 2007). DFUs occur as a result of trauma to or extreme pressure on any part of the foot in diabetics (Veves et al., 1992). The lifetime risk of an individual with diabetes developing a DFU is approximately 25%, according to a meta-analysis of studies conducted during 1980 2004 (Singh et al., 2005). DFUs have become an increasingly significant public health concern in both the developed and the developing world, and are a major cause of hospitalizations, as well the leading cause of lower-extremity amputations, in diabetics (Jeffcoate and Harding, 2003). This report provides an overview of the risk factors, comorbidities, and the global and historical epidemiological trends for DFUs in the six major markets (6MM) (US, France, Germany, Italy, Spain, and UK). In addition, the report includes a 10-year epidemiological forecast for the total prevalent cases of DFUs in the diagnosed diabetic population segmented by age, (ages 20 to >85 years), sex, and the proportion of diabetic foot infections in these markets. GlobalData epidemiologists forecast that the total prevalent cases of DFUs in the 6MM will grow from 3,811,190 cases in 2012 to 5,647,926 cases in 2022, at an Annual Growth Rate (AGR) of 4.82%. According to GlobalData s forecast, diabetic foot infections occur in 58% of the DFU prevalent cases in the 6MM. GlobalData s forecast accounts for the increase in the number of diagnosed diabetic cases, even though the proportion of DFUs remains unchanged over the forecast period. 7

Introduction 2.2 Related Reports GlobalData (2013). EpiCast Report: Type 2 Diabetes Epidemiology Forecast to 2022, June, 2013 8

Appendix 4.3 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India and Singapore. 4.4 About EpiCast EpiCast is a series of premier epidemiology reports written and developed by Masters and PhD level epidemiologists. EpiCast Reports are in-depth, high quality, transparent and market-driven, providing expert analysis of epidemiological trends and forecasting of patient populations for major markets. Specifically, the reports identify disease trends over a 10-year forecast period in six to seven major markets (US, France, Germany, Italy, Spain, UK, Japan). Additional countries, such as Canada, Brazil, India and China, are covered in these reports if their markets are highly relevant. 41

Appendix 4.5 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. 42